Quality Compliance Analyst (GMP/ISO 13485)

Anika Therapeutics; Bedford (MA); On-site; USD 66,000 - 82,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

401(k) with company match

Employee stock purchase plan

Paid time off

Job summary

Anika Therapeutics seeks a QA Compliance Specialist for our Bedford, MA on-site facility to ensure manufacturing operations meet quality, regulatory, and documentation requirements. You will review records, support shop-floor QA activities, and assist audits to uphold cGMP and ISO 13485 compliance.

This early-career role offers hands-on experience in quality systems, manufacturing compliance, and product release activities within a regulated medical device environment.

Qualifications

• Bachelor’s degree in Life Sciences or related field; relevant experience may be considered.
• 0–2 years of industry experience; internship experience and GMP/ISO familiarity are considered.
• Strong organizational skills and attention to detail.
• Excellent written and verbal communication skills.
• Ability to follow procedures, maintain accurate documentation, and work effectively with cross-functional teams.

Responsibilities

• Review batch records and Certificates of Analysis (COAs) for accuracy and completeness prior to final product release.
• Review and approve supplemental logs, charts, and other documentation supporting cGMP manufacturing operations.
• Provide shop-floor Quality Assurance support to Production, including line clearances, in-process checks, and assistance with quality-related issues.
• Support investigations involving nonconformances, CAPAs, root cause analysis, product complaints, out-of-specification events, and environmental excursions.
• Provide Quality Assurance input and support for change controls and planned deviations.
• Provide document control support and help ensure quality documentation is maintained in accordance with applicable procedures and requirements.
• Issue and reconcile batch records to support manufacturing operations.
• Maintain Device History Records (DHRs) to ensure accurate and complete documentation of manufacturing activities.
• Support internal and external audits, including customer and regulatory audits, as part of the Audit Team.
• Assist in maintaining and improving the Quality System to support ongoing compliance with cGMP, ISO 13485, and internal quality requirements.
• Participate in cross-functional project teams and contribute to quality and compliance initiatives.
• Perform other related duties as assigned.

Skills

Detail oriented

Organizational skills

Written and verbal communication

Cross-functional collaboration

Computer proficiency

Education

Bachelor's degree in Life Sciences

Tools

Databases

Microsoft Office

Job description

Anika Therapeutics seeks a QA Compliance Specialist for our Bedford, MA on-site facility to ensure manufacturing operations meet quality, regulatory, and documentation requirements. You will review records, support shop-floor QA activities, and assist audits to uphold cGMP and ISO 13485 compliance.

This early-career role offers hands-on experience in quality systems, manufacturing compliance, and product release activities within a regulated medical device environment.